Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00221429
Status:
COMPLETED
Last Update Posted:
2024-02-08
First Post:
2005-09-14
Brief Title:
Lithium Versus Divalproex for Treating Pediatric Bipolar Disorder
Sponsor:
Childrens Hospital Medical Center Cincinnati
Organization:
Childrens Hospital Medical Center Cincinnati
Study Overview
Official Title:
Pediatric Bipolar Collaborative Mood Stabilizer Trial
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PBC
Brief Summary:
This study compared the efficacy of lithium divalproex and placebo in treating the acute phase of symptomatic bipolar I disorder mixed or manic episode in children and adolescents
Detailed Description:
Primary Aim
To compare the efficacy of lithium LI divalproex DVP and placebo PBO in the acute phase treatment of symptomatic bipolar I disorder mixed or manic episode in children and adolescents Our hypothesis is that differential efficacy will be observed with the following predicted order of response divalproex DVP lithium LI placebo PBO
Secondary Aims
1 To collect systematic safety data on the incidence of weight gain and the development of insulin resistance and hyperandrogenism in bipolar adolescent females treated with LI DVP or LI DVP
2 To collect data on possible predictors of acute treatment response to the two active treatments
3 To provide descriptive information on the stability of acute phase response to monotherapy with either LI or DVP over 6 months of continuation phase treatment
4 To develop safety and efficacy data about the use of stimulant medications in these subject while treated with a mood stabilizer
To compare the efficacy of lithium LI divalproex DVP and placebo PBO in the acute phase treatment of symptomatic bipolar I disorder mixed or manic episode in children and adolescents Our hypothesis is that differential efficacy will be observed with the following predicted order of response divalproex DVP lithium LI placebo PBO
Secondary Aims
1 To collect systematic safety data on the incidence of weight gain and the development of insulin resistance and hyperandrogenism in bipolar adolescent females treated with LI DVP or LI DVP
2 To collect data on possible predictors of acute treatment response to the two active treatments
3 To provide descriptive information on the stability of acute phase response to monotherapy with either LI or DVP over 6 months of continuation phase treatment
4 To develop safety and efficacy data about the use of stimulant medications in these subject while treated with a mood stabilizer
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DSIR CT-M | US NIH GrantContract | None | httpsreporternihgovquickSearchR01MH063632 |
| R01MH063632 | NIH | None | None |